KORU Medical Shares Surge On FDA Approval For FreedomEdge Infusion Pump

  • The FDA gave 510k clearance to Repro Med Systems Inc dba KORU Medical Systems KRMD FreedomEdge infusion pump.
  • The approval comes for the delivery of Hizentra [immune globulin subcutaneous (human) 20% liquid] 20 mL prefilled syringes.
  • Hizentra is indicated for primary immune deficiency (Pl) in patients 2 years and older and as maintenance therapy for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.
  • The Company posted Q3 sales of $6.0 million, (0.7)% Y/Y lower. Adjusted net revenue grew 9%, with growth in all business areas; domestic core driven by pumps, international was driven by consumables.
  • The gross margin was 57.9%, a decline from the prior year of 64.8%, driven by delays in the transition to the second manufacturing facility. 
  • Net loss was $(1.1) million, compared with net income of $0.2 million.
  • Price Action: KRMD shares are up 8.51% at $3.06 during the premarket session on the last check Thursday.
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